eprintid: 10079834 rev_number: 18 eprint_status: archive userid: 608 dir: disk0/10/07/98/34 datestamp: 2019-08-20 09:40:06 lastmod: 2021-12-13 01:59:20 status_changed: 2019-08-20 09:40:06 type: article metadata_visibility: show creators_name: Dunn, DT creators_name: Glidden, DV title: The Connection between the Averted Infections Ratio and the Rate Ratio in Active-control Trials of Pre-exposure Prophylaxis Agents ispublished: pub divisions: UCL divisions: B02 divisions: D65 divisions: J38 keywords: hiv, non-inferiority, active-control trials note: his work is licensed under the Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 License. https://creativecommons.org/licenses/by-nc-nd/4.0/ abstract: The design and analysis of active-control trials to evaluate experimental HIV pre-exposure prophylaxis (PrEP) agents pose serious statistical challenges. We recently proposed a new outcome measure, the averted infections ratio (AIR) – the proportion of infections that would be averted by using the experimental agent rather than the control agent (compared to no intervention). The main aim of the current paper is to examine the mathematical connection between AIR and the HIV incidence rate ratio, the standard outcome measure. We also consider the sample size implications of the choice of primary outcome measure and explore the connection between effectiveness and efficacy under a simplified model of adherence. date: 2019-07-12 date_type: published publisher: Walter de Gruyter GmbH official_url: https://doi.org/10.1515/scid-2019-0006 oa_status: green full_text_type: pub language: eng primo: open primo_central: open_green verified: verified_manual elements_id: 1682460 doi: 10.1515/scid-2019-0006 lyricists_name: Dunn, David lyricists_id: DTDUN70 actors_name: Dunn, David actors_id: DTDUN70 actors_role: owner full_text_status: public publication: Statistical Communications in Infectious Diseases volume: 11 number: 1 article_number: 20190006 issn: 1948-4690 citation: Dunn, DT; Glidden, DV; (2019) The Connection between the Averted Infections Ratio and the Rate Ratio in Active-control Trials of Pre-exposure Prophylaxis Agents. Statistical Communications in Infectious Diseases , 11 (1) , Article 20190006. 10.1515/scid-2019-0006 <https://doi.org/10.1515/scid-2019-0006>. Green open access document_url: https://discovery.ucl.ac.uk/id/eprint/10079834/1/%5BStatistical%20Communications%20in%20Infectious%20Diseases%5D%20The%20Connection%20between%20the%20Averted%20Infections%20Ratio%20and%20the%20Rate%20Ratio%20in%20Active-control%20Trials%20of%20Pre-exposure%20Prophylaxis%20Agents.pdf